Avid Bioservices Inc (CDMO)

[Fire Fox]

The FDAs view of AA in the Phase III lung trial could be heavily influenced by before and after Bavi biopsy data from other clinical trials.

A year from now the biopsy data collected from (1) the pending IST trials, (2) the pending Bavi/Yervoy trial and (3) other new trials, will have established clearly how Bavi transforms the tumor micro environment (TME) from M2 to M1 macrophage phenotype and from immature to mature Dendritic Cells.

There is so much confirmation already published in peer reviewed journals of the importance of these TME biomarkers as indicators for the success of immunotherapy, that the FDA may well accept that Bavi's ability to affect the TME in this way represents "a surrogate endpoint that is reasonably likely to predict clinical benefit", i.e. the standard for AA.

This is another reason why the pending Bavi liver trial is so important. They are collecting TME biopsy data from the liver IST trial. If they can get confirmation in humans of the same TME effects that Thorpe showed in peer-reviewed animal studies, the FDA will be under huge pressure, about a year from now, to accept these surrogate immunotherapy endpoints as indicators of clinical benefit, … and therefore AA.

All IMO.